8(17)
8.5 Reconnect PressureWire
®
to the transmitter, taking care to gently and fully insert
the male connector and to tighten the cap on the transmitter.
8.6 Treat the lesion using standard practice.
8.7 To evaluate the result of the intervention, withdraw the interventional device and
perform pressure measurement.
CAUTION:
An interventional device may cause an underestimation of coronary pressure if left in
artery or guiding catheter during pressure measurement.
NOTE:
To calculate Fractional Flow Reserve (FFR) apply maximum hyperemic
stimulus according to clinical standard practice.
CAUTION:
Failure to achieve maximum coronary and myocardial hyperemia may result in invalid
FFR.
8.8 When the procedure is finished, verify pressures by:
o
Position the sensor element of PressureWire
®
just outside of the tip of the
guiding catheter.
o
Flush any remaining contrast fluids.
o
Pull back the insertion tool out of the hemostatic valve.
o
Tighten the hemostatic valve.
o
Verify that the pressures registered by the guiding catheter and
PressureWire® are the same.
9. DIRECTIONS FOR USE, INTRACARDIAC MEASUREMENTS
WARNING:
When introducing the guidewire, confirm that the catheter tip is free within the heart
lumen and not against the heart wall. Failure to do so may result in ventricle trauma
upon guidewire exit of the catheter.
WARNING:
Torquing PressureWire
®
against resistance may cause damage and/or fracture of
PressureWire®, which may lead to a portion of PressureWire® separating from the
tip.
WARNING:
Positioning of catheters and guide wires in the ventricles is potential arrhythmogenic.
It should never be done without ECG monitoring and the presence of a functioning
defibrillator.
